• Alleviating perineal trauma - the APT study

      Steen, Mary; Marchant, Paul; Leeds Teaching Hospitals NHS Trust/Leeds Metropolitan University (Royal College of Midwives, 2001-08)
      The objectives of this study were to evaluate the effectiveness of a new cooling device (gel pad) and compare it with a standard regimen (ice pack) and a no localised treatment regimen (control). The study was a randomised controlled trial, initially based in a hospital midwifery unit in the North of England and then continued in the community. Participants were 450 women who had undergone either a normal or an instrumental delivery that required suturing of an episiotomy or second degree tear. The measurements and findings were as follows: 316 (71%) of completed questionnaires were returned. A significant reduction in the levels of oedema was observed in favour of using cooling treatments at day two and day five, p=0.016. p=0.018, and there was a significant reduction in bruising at day ten, p=0.01 (using the Kruskal-Wallis test). Self-reported pain was less in the cooling gel pad group. A significant reduction in pain was demonstrated at day five, day ten and day 14, p=0.023, p=0.007, p=0.058, (Kruskal-Wallis test). A reduction in pain was reported earlier on day two, day three and day five when making a binary comparison of moderate or severe pain, with none or mild, p=0.0038, p=0.037, p=0.017 (chi-squared test). Maternal satisfaction With the cooling gel pad was high and differed statistically significantly compared to the other regimens, p=0.0005, (Kruskal-Wallis test). There were no clinical significant differences monitored between groups when assessing healing. The key conclusions were that this clinical trial confirms earlier findings in a previous study and provides evidence that the use of a specifically designed cooling gel pad is a safe and effective localised method to alleviate perineal trauma, without any adverse effects on healing.
    • Ice packs and cooling gel pads versus no localised treatment for relief of perineal pain: A randomised controlled trial

      Steen, Mary; Marchant, Paul; Royal College of Midwives/University of Central Lancashire ; Leeds Metropolitan University (TenAlps, 2007-06-01)
      Background: Trauma to the perineum is extremely common during childbirth and the intensity of perineal pain has been reported to vary from being mild to very severe in nature. Aim: To evaluate the effectiveness of two localised cooling treatments (ice pack and cooling gel pad) compared with a no localised treatment group at relieving perineal pain. Method: A randomised controlled trial conducted in a large maternity unit in the north of England and followed up in women's own homes in which 450 women who had either undergone a normal or instrumental delivery that required suturing of an episiotomy or second-degree tear were randomly assigned to three treatment groups. Results: The response rate was 316 out of 450(71%). Perineal pain was most severe when sitting compared to lying down or walking and there was a significant difference between the three groups in estimates of overall pain when sitting on day four (Kruskal-Wallis test,df=2 p=0.01). Estimates of overall pain were lower in the gel pad group, and the difference between the three groups was significant at days five and day ten (Kruskal-Wallis test,df=2 p=0.02, p=0.01). On days two, three and five, significance was measured when making a binary comparison of reported 'moderate' or 'severe' pain with 'none' or 'mild' (chi-square test, p=0.04,p=0.04, p=0.02). Using a summary pain measurement, mothers experienced fewer painful days in the gel pad group but this did not reach statistical significance (Kruskal-Wallis test, df=2 p=0.26). The use of analgesia was reported to be similar in all three groups. Maternal satisfaction with their overall care was rated more highly in the gel pad group when compared to the two other groups (Kruskal-Wallis test, df=2 p>0.001). Conclusions: Cooling treatments can alleviate pain when compared to no localised treatment. Women appeared to find the cooling gel pad to be a more acceptable treatment.
    • A randomised controlled trial to compare the effectiveness of ice-packs and Epifoam with cooling maternity gel pads at alleviating postnatal perineal trauma

      Steen, Mary; Cooper, Keith; Marchant, Paul; Griffiths-Jones, Martin; Walker, James; Community Midwifery Office, St James University Hospital, Leeds (Churchill Livingstone, 2000-03)
      OBJECTIVE: To evaluate the effectiveness of standard regimes (ice packs and Epifoam) at relieving perineal trauma and compare these with a new cooling device (maternity gel pad). DESIGN: A randomised controlled trial involving three treatment groups. The women were free to choose the time of initial application (within four hours after delivery) in all treatment groups and the number of subsequent treatments up to 48 hours after suturing. SETTING: A midwifery unit in the north of England and then continued in the women's own homes. PARTICIPANTS: 120 women who had undergone an instrumental delivery and had a 48 hours post-delivery stay in a postnatal ward. MEASUREMENTS AND FINDINGS: The ordinal scale of none, mild, moderate and severe was used to determine the levels of perineal oedema and bruising at initial assessment (less than 4 hours), 24 hours and at 48 hours, by use of a newly developed visual evaluating tool. Self-assessed pain was recorded using a 10-point visual analogue scale within four hours, at 24 hours, 48 hours, and finally at five days after suturing. Women's opinions as to the effectiveness of their treatment was rated by use of a 5-point scale describing the categories; poor, fair, good, very good and excellent. A high proportion of women had some perineal oedema at initial assessment. A statistically significant difference in the proportion of women with oedema was found between treatment groups at 48 hours (p = 0.01), which was in favour of the maternity gel pad group. This was particularly noticeable for women with initial levels of mild oedema (p = 0.017). Localised treatment with the gel pad caused a significant decrease in reported pain at 48 hours in women who initially demonstrated moderate or severe pain (p = 0.048). A significant increase in the proportion of women with some bruising was seen across all treatment groups from initial assessment, through 24 hours to 48 hours (p < 0.0005). The bruising was significantly less in the gel-pad group in women who initially had no bruising (p = 0.021). There was no statistically significant effect of treatment at other initial levels of severity for oedema, bruising or pain at 24 hours, 48 hours and five days (for pain). Women in the gel-pad group rated the effectiveness of their localised treatment to be significantly higher than women in the other two treatment groups (p < 0.0005). KEY CONCLUSIONS: This trial demonstrated that a high proportion of women experience perineal oedema, bruising and pain following an instrumental delivery, which continues for at least five days for perineal pain, despite oral analgesia. Maternity gel pads, which were specially designed to cool the perineal region, were more effective in alleviating perineal trauma when compared with hospital standard regimens and were more highly rated by women.